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ATORVASTATIN CALCIUM
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Atorvastatin Calcium Propylene Glycol Solvate | 10 mg/1 | 617310 | — |
| Atorvastatin Calcium Propylene Glycol Solvate | 20 mg/1 | 617310 | — |
| Atorvastatin Calcium Propylene Glycol Solvate | 40 mg/1 | 617310 | — |
| Atorvastatin Calcium Propylene Glycol Solvate | 80 mg/1 | 617310 | — |
| Atorvastatin Calcium Trihydrate | 10 mg/1 | 259255 | View |
| Atorvastatin Calcium Trihydrate | 20 mg/1 | 259255 | View |
| Atorvastatin Calcium Trihydrate | 40 mg/1 | 259255 | View |
| Atorvastatin Calcium Trihydrate | 80 mg/1 | 259255 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| HMG-CoA Reductase Inhibitor [EPC] | EPC | All 33 members |
| Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] | MoA | All 33 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 090548-001 | ATORVASTATIN CALCIUM | TABLET | ATORVASTATIN CALCIUM | Prescription | AB | ||
| 090548-002 | ATORVASTATIN CALCIUM | TABLET | ATORVASTATIN CALCIUM | Prescription | AB | ||
| 090548-003 | ATORVASTATIN CALCIUM | TABLET | ATORVASTATIN CALCIUM | Prescription | AB | ||
| 090548-004 | ATORVASTATIN CALCIUM | TABLET | ATORVASTATIN CALCIUM | Prescription | AB |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 31 | Labeling | Approved | December 4, 2024 | Standard |
| Supplement | 27 | Labeling | Approved | July 25, 2023 | Standard |
| Supplement | 26 | Labeling | Approved | July 25, 2023 | Standard |
| Supplement | 25 | Labeling | Approved | July 25, 2023 | Standard |
| Supplement | 23 | Labeling | Approved | November 4, 2019 | Standard |
| Supplement | 19 | Labeling | Approved | January 17, 2019 | Standard |
| Supplement | 17 | Labeling | Approved | June 7, 2018 | Standard |
| Supplement | 16 | Labeling | Approved | June 7, 2018 | Standard |
| Supplement | 11 | Labeling | Approved | October 6, 2015 | Standard |
| Supplement | 10 | Labeling | Approved | April 28, 2015 | Standard |
| Supplement | 3 | Labeling | Approved | April 6, 2015 | Standard |
| Original application | 1 | Approved | May 29, 2012 | — |
Review documents
- 0 · Original application · March 9, 2015
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260730). This is the manufacturer's labelling text, not a summary and not advice.
Recent Major Changes
openFDA Drug LabelingDosage and Administration, Dosage in Patients Taking Cyclosporine, Clarithromycin, Itraconazole, Letermovir, or Certain Protease Inhibitors (2.6) 11/2019 Warnings and Precautions, Myopathy and Rhabdomyolysis (5.1) 11/2020 Warnings and Precautions, Immune-Mediated Necrotizing Myopathy (5.2) 9/2020
Indications and Usage
openFDA Drug Labeling1 INDICATIONS AND USAGE Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet. Atorvastatin calcium tablets are HMG-CoA reductase inhibitor indicated as an adjunct therapy to diet to: • Reduce the risk of MI, stroke, revascularization procedures, and angina in adult patients without CHD, but with multiple risk factors (1.1). • Reduce the risk of MI, stroke, revascularization procedures, and angina in adult patients without CHD, but with multiple risk factors (1.1). • Reduce the risk of MI and stroke in adult patients with type 2 diabetes without CHD, but with multiple risk factors (1.1). • Reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for CHF, and angina in adult patients with CHD (1.1). • Reduce elevated total-C, LDL-C, apo B, and TG levels and increase HDL-C in adult patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (1.2). • Reduce elevated TG in adult patients with hypertriglyceridemia and primary dysbetalipoproteinemia (1.2). • Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) (1.2). • Reduce elevated total-C, LDL-C, and apo B levels in pediatric patients, 10 years to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) after failing an adequate trial of diet therapy (1.2). Limitations of Use Atorvastatin calcium tablets have not been studied in Fredrickson Types I and V dyslipidemias (1.3). 1.1 Prevention of Cardiovascular Disease in Adults In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, atorvastatin calcium tablets are indicated to: • Reduce the risk of myocardial infarction • Reduce the risk of stroke • Reduce the risk for revascularization procedures and angina In adult patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, atorvastatin calcium tablets are indicated to: • Reduce the risk of myocardial infarction • Reduce the risk of stroke In adult patients with clinically evident coronary heart disease, atorvastatin calcium tablets are indicated to: • Reduce the risk of non-fatal myocardial infarction • Reduce the risk of fatal and non-fatal stroke • Reduce the risk for revascularization procedures • Reduce the risk of hospitalization for CHF • Reduce the risk of angina 1.2 Hyperlipidemia Atorvastatin calcium tablets are indicated: • As an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in adult patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia ( Fredrickson Types IIa and IIb); • As an adjunct to diet for the treatment of adult patients with elevated serum TG levels ( Fredrickson Type IV);•For the treatment of adult patients with primary dysbetalipoproteinemia ( Fredrickson Type III) who do not respond adequately to diet; • To reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable; • As an adjunct to diet to reduce total-C, LDL-C, and apo B levels in pediatric patients, 10 years to 17 years of age, with heterozygous familial hyp …
Dosage and Administration
openFDA Drug Labeling2 DOSAGE AND ADMINISTRATION Dose range: 10 to 80 mg once daily ( 2.1 ). Recommended start dose: 10 or 20 mg once daily ( 2.1 ). Patients requiring large LDL-C reduction (>45%) may start at 40 mg once daily ( 2.1 ). Pediatric patients with HeFH: starting dose: 10 mg once daily; dose range: 10 to 20 mg/day for patients 10 years to 17 years of age ( 2.2 ). 2.1 Hyperlipidemia and Mixed Dyslipidemia The recommended starting dose of atorvastatin calcium tablets is 10 or 20 mg once daily. Patients who require a large reduction in LDL-C (more than 45%) may be started at 40 mg once daily. The dosage range of atorvastatin calcium tablets is 10 to 80 mg once daily. Atorvastatin calcium tablets can be administered as a single dose at any time of the day, with or without food. The starting dose and maintenance doses of atorvastatin calcium tablets should be individualized according to patient characteristics such as goal of therapy and response. After initiation and/or upon titration of atorvastatin calcium tablets, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly. 2.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 Years to17 Years of Age) The recommended starting dose of atorvastatin calcium tablets is 10 mg/day; the usual dose range is 10 to 20 mg orally once daily [ see Clinical Studies (14.6 )]. Doses should be individualized according to the recommended goal of therapy [ see Indications and Usage (1.2) and Clinical Pharmacology (12) ]. Adjustments should be made at intervals of 4 weeks or more. 2.3 Homozygous Familial Hypercholesterolemia The dosage of atorvastatin calcium tablets in patients with HoFH is 10 to 80 mg daily. Atorvastatin calcium tablets should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable. 2.4 Concomitant Lipid-Lowering Therapy Atorvastatin calcium tablets may be used with bile acid resins. The combination of HMG-CoA reductase inhibitors (statins) and fibrates should generally be used with caution [ see Warnings and Precautions (5.1) and Drug Interactions (7) ]. 2.5 Dosage in Patients with Renal Impairment Renal disease does not affect the plasma concentrations nor LDL-C reduction of atorvastatin calcium tablets; thus, dosage adjustment in patients with renal dysfunction is not necessary [ see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ]. 2.6 Dosage in Patients Taking Cyclosporine, Clarithromycin, Itraconazole, or Certain Protease Inhibitors In tablets should be avoided. In patients with HIV taking lopinavir plus ritonavir, use the lowest dose necessary of atorvastatin calcium tablets. In patients taking clarithromycin, itraconazole, elbasvir plus grazoprevir, or in patients with HIV taking a combination of saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, therapy with atorvastatin calcium tablets should be limited to 20 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin calcium tablets is used. In patients taking the HIV protease inhibitor nelfinavir therapy with atorvastatin calcium tablets should be limited to 40 mg. When co-prescribing atorvastatin with other protease inhibitors, appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin calcium tablets is used In patients taking cyclosporine or the HIV protease inhibitor tipranavir plus ritonavir or the hepatitis C virus (HCV) protease inhibitor glecaprevir plus pibrentasvir, therapy with atorvastatin calcium tablets should be avoided. In patients with HIV taking lopinavir plus ritonavir, use the lowest dose necessary of atorvastatin calcium tablets. In patients taking clarithromycin, itraconazole, elbasvir plus grazoprevir, or in patients with HIV taking a combination of saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosa …
Dosage Forms and Strengths
openFDA Drug Labeling3 DOSAGE FORMS AND STRENGTHS Atorvastatin calcium tablets, USP are white, elliptical, film-coated tablets containing atorvastatin calcium trihydrate, USP equivalent to 10, 20, 40, and 80 mg atorvastatin. Table 1: Atorvastatin calcium Tablet Strengths and Identifying Features Tablet Strength Identifying Features 10 mg of atorvastatin white, elliptical, film-coated tablets, debossed with ‘RX 12’ on one side and plain on the other side. 20 mg of atorvastatin white, elliptical, film-coated tablets, debossed with ‘RX 828’ on one side and plain on the other side 40 mg of atorvastatin white, elliptical, film-coated tablets, debossed with ‘RX 829’ on one side and plain on the other side. 80 mg of atorvastatin white, elliptical, film-coated tablets, debossed with ‘RX 830’ on one side and plain on the other side. Tablets: 10, 20, 40, and 80 mg of atorvastatin (3).
Contraindications
openFDA Drug Labeling4 CONTRAINDICATIONS Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels ( Error! Hyperlink reference not valid. ). Women who are pregnant or may become pregnant ( 4.3 ). Nursing mothers ( 4.4 ). Hypersensitivity to any component of this medication ( Error! Hyperlink reference not valid. ). 4.1 Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels 4.2 Hypersensitivity to any Component of this Medication 4.3 Pregnancy Women who are pregnant or may become pregnant. Atorvastatin calcium may cause fetal harm when administered to a pregnant woman. Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol or cholesterol derivatives are essential for fetal development. Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. There are no adequate and well-controlled studies of atorvastatin calcium use during pregnancy; however in rare reports, congenital anomalies were observed following intrauterine exposure to statins. In rat and rabbit animal reproduction studies, atorvastatin revealed no evidence of teratogenicity. ATORVASTATIN CALCIUM SHOULD BE ADMINISTERED TO WOMEN OF CHILDBEARING AGE ONLY WHEN SUCH PATIENTS ARE HIGHLY UNLIKELY TO CONCEIVE AND HAVE BEEN INFORMED OF THE POTENTIAL HAZARDS. If the patient becomes pregnant while taking this drug, atorvastatin calcium should be discontinued immediately and the patient apprised of the potential hazard to the fetus [see Use in Specific Populations (8.1) ] . 4.4 Nursing mothers It is not known whether atorvastatin is excreted into human milk; however a small amount of another drug in this class does pass into breast milk. Because statins have the potential for serious adverse reactions in nursing infants, women who require atorvastatin calcium treatment should not breastfeed their infants [see Use in Specific Populations (8.3) ] .
Warnings and Cautions
openFDA Drug Labeling5 WARNINGS AND PRECAUTIONS Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase when higher doses are used concomitantly with cyclosporine and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, HIV protease inhibitors). Predisposing factors include advanced age (> 65), uncontrolled hypothyroidism, and renal impairment. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported. Advise patients to promptly report to their physician unexplained and/or persistent muscle pain, tenderness, or weakness. Atorvastatin calcium therapy should be discontinued if myopathy is diagnosed or suspected ( 5.1 , 8.5 ). Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter ( 5.2 ). A higher incidence of hemorrhagic stroke was seen in patients without CHD but with stroke or TIA within the previous 6 months in the atorvastatin calcium 80 mg group vs. placebo ( 5.5 ). 5.1 Skeletal Muscle Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with atorvastatin calcium and with other drugs in this class. A history of renal impairment may be a risk factor for the development of rhabdomyolysis. Such patients merit closer monitoring for skeletal muscle effects. Atorvastatin, like other statins, occasionally causes myopathy, defined as muscle aches or muscle weakness in conjunction with increases in creatine phosphokinase (CPK) values >10 times ULN. The concomitant use of higher doses of atorvastatin with certain drugs such as cyclosporine and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, and HIV protease inhibitors) increases the risk of myopathy/rhabdomyolysis. There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents. Myopathy should be considered in any patient with diffuse myalgias, muscle tenderness or weakness, and/or marked elevation of CPK. Patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing atorvastatin calcium. Atorvastatin calcium therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. The risk of myopathy during treatment with drugs in this class is increased with concurrent administration of cyclosporine, fibric acid derivatives, erythromycin, clarithromycin, the hepatitis C protease inhibitor telaprevir, combinations of HIV protease inhibitors, including saquinavir plus ritonavir, lopinavir plus ritonavir, tipranavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, and fosamprenavir plus ritonavir, niacin, or azole antifungals. Physicians considering combined therapy with atorvastatin calcium and fibric acid derivatives, erythromycin, clarithromycin, a combination of saquinavir plus ritonavir, lopinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, azole antifungals, or lipid-modifying doses of niacin should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs or symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and during any periods of upward dosage titration of either drug. Lower starting and maintenance doses of atorvastatin should be considered when taken concomitantly with the aforementioned drugs (see Drug Interactions (7)) . Periodic creatine phosphokinase (CPK) determinations may be considered in such …
Adverse Reactions
openFDA Drug Labeling6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Myopathy and Rhabdomyolysis [see Warnings and Precautions ( 5.1 )] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions ( 5.2 )] Hepatic Dysfunction [see Warnings and Precautions ( 5.3 )] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (incidence ≥5%) are nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the atorvastatin calcium placebo-controlled clinical trial database of 16,066 patients (8,755 atorvastatin calcium vs. 7,311 placebo; age range 10 to 93 years, 39% female, 91% White, 3% Black or African American, 2% Asian, 4% other) with a median treatment duration of 53 weeks, the most common adverse reactions in patients treated with atorvastatin calcium that led to treatment discontinuation and occurred at a rate greater than placebo were: myalgia (0.7%), diarrhea (0.5%), nausea (0.4%), alanine aminotransferase increase (0.4%), and hepatic enzyme increase (0.4%). Table 1 summarizes adverse reactions reported in ≥2% and at a rate greater than placebo in patients treated with atorvastatin calcium (n=8,755), from seventeen placebo-controlled trials. Table 1: Adverse Reactions Occurring in ≥2% in Patients Atorvastatin Calcium-Treated with any Dose and Greater than Placebo Adverse Reaction % Placebo N=7,311 %10 mg N=3,908 %20 mg N=188 %40 mg N=604 %80 mg N=4,055 % Any dose N=8,755 Nasopharyngitis 8.2 12.9 5.3 7.0 4.2 8.3 Arthralgia 6.5 8.9 11.7 10.6 4.3 6.9 Diarrhea 6.3 7.3 6.4 14.1 5.2 6.8 Pain in extremity 5.9 8.5 3.7 9.3 3.1 6.0 Urinary tract infection 5.6 6.9 6.4 8.0 4.1 5.7 Dyspepsia 4.3 5.9 3.2 6.0 3.3 4.7 Nausea 3.5 3.7 3.7 7.1 3.8 4.0 Musculoskeletal pain 3.6 5.2 3.2 5.1 2.3 3.8 Muscle spasms 3.0 4.6 4.8 5.1 2.4 3.6 Myalgia 3.1 3.6 5.9 8.4 2.7 3.5 Insomnia 2.9 2.8 1.1 5.3 2.8 3.0 Pharyngolaryngeal pain 2.1 3.9 1.6 2.8 0.7 2.3 Other adverse reactions reported in placebo-controlled trials include: Body as a Whole: malaise, pyrexia Digestive System: abdominal discomfort, eructation, flatulence, hepatitis, cholestasis Musculoskeletal System: musculoskeletal pain, muscle fatigue, neck pain, joint swelling Metabolic and Nutritional System: transaminases increase, liver function test abnormal, blood alkaline phosphatase increase, creatine phosphokinase increase, hyperglycemia Nervous System: nightmare Respiratory System: epistaxis Skin and Appendages: urticaria Special Senses: vision blurred, tinnitus Urogenital System: white blood cells urine positive Elevations in Liver Enzyme Tests Persistent elevations in serum transaminases, defined as more than 3 times the ULN and occurring on 2 or more occasions, occurred in 0.7% of patients who received atorvastatin calcium in clinical trials. The incidence of these abnormalities was 0.2%, 0.2%, 0.6%, and 2.3% for 10, 20, 40, and 80 mg, respectively. One patient in clinical trials developed jaundice. Increases in liver enzyme tests in other patients were not associated with jaundice or other clinical signs or symptoms. Upon dose reduction, drug interruption, or discontinuation, transaminase levels returned to or near pretreatment levels without sequelae. Eighteen of 30 patients with persistent liver enzyme elevations continued treatment with a reduced dose of atorvastatin calcium. Treating to New Targets Study (TNT) In TNT, [see Clinical Studies (14.1)] 10,001 patients (age range 29 to 78 years, 19% female; 94% White, 3% Black or Af …
Drug Interactions
openFDA Drug Labeling7 DRUG INTERACTIONS • See full prescribing information for details regarding concomitant use of atorvastatin calcium tablets with other drugs or grapefruit juice that increase the risk of myopathy and rhabdomyolysis ( 2.5 , 7.1 ). • Rifampin: May reduce atorvastatin plasma concentrations. Administer simultaneously with atorvastatin calcium tablets ( 7.2 ). • Oral Contraceptives: May increase plasma levels of norethindrone and ethinyl estradiol; consider this effect when selecting an oral contraceptive ( 7.3 ). • Digoxin: May increase digoxin plasma levels; monitor patients appropriately ( 7.3 ). 7.1 Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with Atorvastatin Calcium Tablets Atorvastatin is a substrate of CYP3A4 and transporters (e.g., OATP1B1/1B3, P-gp, or BCRP). Atorvastatin plasma levels can be significantly increased with concomitant administration of inhibitors of CYP3A4 and transporters. Table 2 includes a list of drugs that may increase exposure to atorvastatin and may increase the risk of myopathy and rhabdomyolysis when used concomitantly and instructions for preventing or managing them [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ] . Table 2: Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with Atorvastatin Calcium Tablets Cyclosporine or Gemfibrozil Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin calcium tablets and cyclosporine, an inhibitor of CYP3A4 and OATP1B1 [see Clinical Pharmacology (12.3) ] . Gemfibrozil may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of cyclosporine or gemfibrozil with atorvastatin calcium tablets. Intervention: Concomitant use of cyclosporine or gemfibrozil with atorvastatin calcium tablets is not recommended. Anti-Viral Medications Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin calcium tablets with many anti-viral medications, which are inhibitors of CYP3A4 and/or transporters (e.g., BCRP, OATP1B1/1B3, P-gp, MRP2, and/or OAT2) [see Clinical Pharmacology (12.3) ] . Cases of myopathy and rhabdomyolysis have been reported with concomitant use of ledipasvir plus sofosbuvir with atorvastatin calcium tablets. Intervention: • Concomitant use of tipranavir plus ritonavir or glecaprevir plus pibrentasvir with atorvastatin calcium tablets is not recommended. • In patients taking lopinavir plus ritonavir, or simeprevir, consider the risk/benefit of concomitant use with atorvastatin. • In patients taking saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir or letermovir, do not exceed atorvastatin calcium tablets 20 mg. • In patients taking nelfinavir, do not exceed atorvastatin calcium tablets 40 mg [see Dosage and Administration (2.5) ] . • Consider the risk/benefit of concomitant use of ledipasvir plus sofosbuvir with atorvastatin calcium tablets. • Monitor all patients for signs and symptoms of myopathy particularly during initiation of therapy and during upward dose titration of either drug. Examples: Tipranavir plus ritonavir, glecaprevir plus pibrentasvir, lopinavir plus ritonavir, simeprevir, saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir, letermovir, nelfinavir, and ledipasvir plus sofosbuvir. Select Azole Antifungals or Macrolide Antibiotics Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin calcium tablets with select azole antifungals or macrolide antibiotics, due to inhibition of CYP3A4 and/or transporters [see Clinical Pharmacology (12.3) ] . Intervention: In patients taking clarithromycin or itraconazole, do not exceed atorvastatin calcium tablets 20 mg [see Dosage and Administrati …
Use in Specific Populations
openFDA Drug Labeling8 USE IN SPECIFIC POPULATIONS Pregnancy May cause fetal harm. ( 8.1 ). Lactation Breastfeeding not recommended during treatment with atorvastatin calcium tablets ( 8.2 ). 8.1 Pregnancy Risk Summary Discontinue atorvastatin calcium tablets when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Atorvastatin calcium tablets decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, atorvastatin calcium tablets may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1) ]. In addition, treatment of hyperlipidemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations. Published data from prospective and retrospective observational cohort studies with atorvastatin calcium tablets use in pregnant women are insufficient to determine if there is a drug- associated risk of miscarriage ( see Data). In animal reproduction studies, no adverse developmental effects were observed in pregnant rats or rabbits orally administered atorvastatin at doses that resulted in up to 30 and 20 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 80 mg, based on body surface area (mg/m 2 ). In rats administered atorvastatin during gestation and lactation, decreased postnatal growth and development delay were observed at doses ≥ 6 times the MRHD ( see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data A Medicaid cohort linkage study of 1,152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity score-based methods. The relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus. There were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for confounders. In the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. Study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births. Animal Data Atorvastatin was administered to pregnant rats and rabbits during organogenesis at oral doses up to 300 mg/kg/day and 100 mg/kg/day, respectively. Atorvastatin was not teratogenic in rats at doses up to 300 mg/kg/day or in rabbits at doses up to 100 mg/kg/day. These doses resulted in multiples of about 30 times (rat) or 20 times (rabbit) the human exposure at the MRHD based on surface area (mg/m 2 ). In rats, the maternally toxic dose of 300 mg/kg resulted in increased post-implantation loss and decreased fetal body weight. At the maternally …
Mechanism of Action
openFDA Drug Labeling12.1 Mechanism of Action Atorvastatin calcium is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. Cholesterol and triglycerides circulate in the bloodstream as part of lipoprotein complexes. With ultracentrifugation, these complexes separate into HDL (high-density lipoprotein), IDL (intermediate-density lipoprotein), LDL (low-density lipoprotein), and VLDL (very-low-density lipoprotein) fractions. Triglycerides (TG) and cholesterol in the liver are incorporated into VLDL and released into the plasma for delivery to peripheral tissues. LDL is formed from VLDL and is catabolized primarily through the high-affinity LDL receptor. Clinical and pathologic studies show that elevated plasma levels of total cholesterol (total-C), LDL-cholesterol (LDL-C), and apolipoprotein B (apo B) promote human atherosclerosis and are risk factors for developing cardiovascular disease, while increased levels of HDL-C are associated with a decreased cardiovascular risk. In animal models, atorvastatin calcium lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and by increasing the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL; atorvastatin calcium also reduces LDL production and the number of LDL particles. Atorvastatin calcium reduces LDL-C in some patients with homozygous familial hypercholesterolemia (FH), a population that rarely responds to other lipid-lowering medication(s). A variety of clinical studies have demonstrated that elevated levels of total-C, LDL-C, and apo B (a membrane complex for LDL-C) promote human atherosclerosis. Similarly, decreased levels of HDL-C (and its transport complex, apo A) are associated with the development of atherosclerosis. Epidemiologic investigations have established that cardiovascular morbidity and mortality vary directly with the level of total-C and LDL-C, and inversely with the level of HDL-C. Atorvastatin calcium reduces total-C, LDL-C, and apo B in patients with homozygous and heterozygous FH, nonfamilial forms of hypercholesterolemia, and mixed dyslipidemia. Atorvastatin calcium also reduces VLDL-C and TG and produces variable increases in HDL-C and apolipoprotein A-1. Atorvastatin calcium reduces total-C, LDL-C, VLDL-C, apo B, TG, and non-HDL-C, and increases HDL-C in patients with isolated hypertriglyceridemia. Atorvastatin calcium reduces intermediate density lipoprotein cholesterol (IDL-C) in patients with dysbetalipoproteinemia. Like LDL, cholesterol-enriched triglyceride-rich lipoproteins, including VLDL, intermediate density lipoprotein (IDL), and remnants, can also promote atherosclerosis. Elevated plasma triglycerides are frequently found in a triad with low HDL-C levels and small LDL particles, as well as in association with non-lipid metabolic risk factors for coronary heart disease. As such, total plasma TG has not consistently been shown to be an independent risk factor for CHD. Furthermore, the independent effect of raising HDL or lowering TG on the risk of coronary and cardiovascular morbidity and mortality has not been determined.
Description
openFDA Drug Labeling11 DESCRIPTION Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. The drug substance used in atorvastatin calcium tablets, USP is atorvastatin calcium in the form of propylene glycol solvate. The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. The empirical formula of atorvastatin calcium propylene glycol solvate is C 66 H 68 CaF 2 N 4 O 10 * C 3 H 8 O 2 and its molecular weight is 1231.46 g/mol. Its structural formula is: Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: calcium acetate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate (vegetable source), microcrystalline cellulose, polyethylene glycol, sodium carbonate, and titanium dioxide. chemical-structure
Overdosage
openFDA Drug Labeling10 OVERDOSAGE There is no specific treatment for atorvastatin calcium overdosage. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required. Due to extensive drug binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin calcium clearance.
How Supplied / Storage and Handling
openFDA Drug Labeling16 HOW SUPPLIED/STORAGE AND HANDLING Atorvastatin Calcium Tablets, USP are supplied as follows: 10 mg: White elliptical shaped, film coated tablets, debossed with '10' on one side and 'ATS' on other side. Bottle of 20 NDC 76420-943-20 (repackaged from NDC 67877-511-XX) Bottle of 30 NDC 76420-943-30 (repackaged from NDC 67877-511-XX) Bottle of 60 NDC 76420-943-60 (repackaged from NDC 67877-511-XX) Bottle of 90 NDC 76420-943-90 (relabeled from NDC 67877-511-90) Bottle of 120 NDC 76420-943-12 (repackaged from NDC 67877-511-XX) Bottle of 500 NDC 76420-943-05 (relabeled from NDC 67877-511-05) Bottle of 1000 NDC 76420-943-00 (relabeled from NDC 67877-511-10) Bottle of 5000 NDC 76420-943-55 (relabeled from NDC 67877-511-55) Carton of 100 (10 x 10 unit-dose) tablets NDC 76420-943-38 (relabeled from NDC 67877-511-38) 20 mg: White elliptical shaped, film coated tablets, debossed with '20' on one side and 'ATS' on other side. Bottle of 20 NDC 76420-945-20 (repackaged from NDC 67877-512-XX) Bottle of 30 NDC 76420-945-30 (repackaged from NDC 67877-512-XX) Bottle of 60 NDC 76420-945-60 (repackaged from NDC 67877-512-XX) Bottle of 90 NDC 76420-945-90 (relabeled/repackaged from NDC 67877-512-90) Bottle of 120 NDC 76420-945-12 (repackaged from NDC 67877-512-XX) Bottle of 500 NDC 76420-945-05 (relabeled from NDC 67877-512-05) Bottle of 1000 NDC 76420-945-00 (relabeled from NDC 67877-512-10) Bottle of 4000 NDC 76420-945-44 (relabeled from NDC 67877-512-44) Carton of 100 (10 x 10 unit-dose) tablets NDC 76420-945-38 (relabeled from NDC 67877-512-38) 40 mg: White elliptical shaped, film coated tablets, debossed with '40' on one side and 'ATS' on other side. Bottle of 20 NDC 76420-946-20 (repackaged from NDC 67877-513-XX) Bottle of 30 NDC 76420-946-30 (repackaged from NDC 67877-513-XX) Bottle of 60 NDC 76420-946-60 (repackaged from NDC 67877-513-XX) Bottle of 90 NDC 76420-946-90 (relabeled from NDC 67877-513-90) Bottle of 120 NDC 76420-946-12 (repackaged from NDC 67877-513-XX) Bottle of 500 NDC 76420-946-05 (relabeled from NDC 67877-513-05) Bottle of 1000 NDC 76420-946-00 (relabeled from NDC 67877-513-10) Bottle of 2000 NDC 76420-946-23 (relabeled from NDC 67877-513-23) Carton of 100 (10 x 10 unit-dose) tablets NDC 76420-946-38 (relabeled from NDC 67877-513-38) 80 mg: White elliptical shaped, film coated tablets, debossed with '80' on one side and 'ATS' on other side. Bottle of 20 NDC 76420-948-20 (repackaged from NDC 67877-514-XX) Bottle of 30 NDC 76420-948-30 (repackaged from NDC 67877-514-XX) Bottle of 60 NDC 76420-948-60 (repackaged from NDC 67877-514-XX) Bottle of 90 NDC 76420-948-90 (relabeled from NDC 67877-514-90) Bottle of 120 NDC 76420-948-12 (repackaged from NDC 67877-514-XX) Bottle of 500 NDC 76420-948-05 (relabeled from NDC 67877-514-05) Bottle of 1000 NDC 76420-948-00 (relabeled from NDC 67877-514-10) Carton of 100 (10 x 10 unit-dose) tablets NDC 76420-948-38 (relabeled from NDC 67877-514-38) Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: ATORVASTATIN CALCIUM TRIHYDRATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Recalls
Source: FDA Enforcement| Classification | Reported | Firm | Reason | Status |
|---|---|---|---|---|
| Class II | October 22, 2025 | Ascend Laboratories, LLC | Failed Dissolution Specifications | Ongoing |
| Class II | October 22, 2025 | Ascend Laboratories, LLC | Failed Dissolution Specifications | Ongoing |
| Class II | October 22, 2025 | Ascend Laboratories, LLC | Failed Dissolution Specifications | Ongoing |
| Class II | October 22, 2025 | Ascend Laboratories, LLC | Failed Dissolution Specifications | Ongoing |
| Class II | April 9, 2025 | BIOCON PHARMA INC | Failed dissolution specifications: lower than specifications | Ongoing |
| Class II | May 3, 2023 | Northwind Pharmaceuticals LLC | CGMP Deviations | Ongoing |
| Class II | March 8, 2023 | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. | Terminated |
| Class II | March 8, 2023 | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. | Terminated |
| Class II | March 8, 2023 | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. | Terminated |
| Class II | March 8, 2023 | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. | Terminated |
| Class II | March 25, 2020 | Sun Pharmaceutical Industries, Inc. | Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg. | Terminated |
| Class III | November 6, 2019 | Apotex Inc. | Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg. | Terminated |
| Class II | April 5, 2017 | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. | Terminated |
| Class II | April 5, 2017 | Mylan Pharmaceuticals Inc. | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. | Terminated |
| Class II | April 5, 2017 | Mylan Pharmaceuticals Inc. | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. | Terminated |
| Class II | April 5, 2017 | Mylan Pharmaceuticals Inc. | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. | Terminated |
| Class II | April 5, 2017 | Mylan Pharmaceuticals Inc. | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. | Terminated |
| Class II | March 5, 2014 | Ranbaxy Inc. | Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg. | Terminated |
| Class II | December 5, 2012 | Ranbaxy Inc. | Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. | Terminated |
| Class II | December 5, 2012 | Ranbaxy Inc. | Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. | Terminated |
| Class II | December 5, 2012 | Ranbaxy Inc. | Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. | Terminated |
| Class II | November 28, 2012 | Ranbaxy Inc. | Adulterated Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg. | Terminated |
| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-5181-0 | 50090-5181 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-5181-0) | September 28, 2020 |
| 50090-5181-1 | 50090-5181 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-5181-1) | September 28, 2020 |
| 50090-5181-2 | 50090-5181 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-5181-2) | March 8, 2023 |
| 50090-5182-0 | 50090-5182 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-5182-0) | September 28, 2020 |
| 50090-5184-0 | 50090-5184 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-5184-0) | September 29, 2020 |
| 50090-5184-1 | 50090-5184 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-5184-1) | September 29, 2020 |
| 50090-5184-2 | 50090-5184 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-5184-2) | March 7, 2023 |
| 50090-5207-0 | 50090-5207 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-5207-0) | October 5, 2020 |
| 50090-5207-1 | 50090-5207 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-5207-1) | October 5, 2020 |
| 50090-5207-2 | 50090-5207 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-5207-2) | September 13, 2023 |
| 50090-5208-0 | 50090-5208 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-5208-0) | October 5, 2020 |
| 50090-5915-0 | 50090-5915 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-5915-0) | February 9, 2022 |
| 50090-5915-1 | 50090-5915 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-5915-1) | February 9, 2022 |
| 50090-5915-2 | 50090-5915 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-5915-2) | November 5, 2023 |
| 50090-6054-0 | 50090-6054 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6054-0) | August 24, 2022 |
| 50090-6054-1 | 50090-6054 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6054-1) | August 24, 2022 |
| 50090-6054-2 | 50090-6054 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-6054-2) | April 3, 2023 |
| 50090-6061-0 | 50090-6061 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6061-0) | August 26, 2022 |
| 50090-6061-1 | 50090-6061 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6061-1) | August 26, 2022 |
| 50090-6061-2 | 50090-6061 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-6061-2) | March 7, 2023 |
| 50090-6440-0 | 50090-6440 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6440-0) | April 17, 2023 |
| 50090-6440-1 | 50090-6440 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6440-1) | April 17, 2023 |
| 50090-6440-2 | 50090-6440 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-6440-2) | April 17, 2023 |
| 50090-6441-0 | 50090-6441 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6441-0) | April 17, 2023 |
| 50090-6479-0 | 50090-6479 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6479-0) | May 17, 2023 |
| 50090-6479-1 | 50090-6479 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6479-1) | May 17, 2023 |
| 50090-6479-2 | 50090-6479 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-6479-2) | May 17, 2023 |
| 50090-6480-0 | 50090-6480 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6480-0) | May 17, 2023 |
| 50090-6481-0 | 50090-6481 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6481-0) | May 17, 2023 |
| 50090-6481-1 | 50090-6481 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6481-1) | May 17, 2023 |
| 50090-6481-2 | 50090-6481 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-6481-2) | May 17, 2023 |
| 50090-6482-0 | 50090-6482 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6482-0) | May 17, 2023 |
| 50090-6505-0 | 50090-6505 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6505-0) | May 30, 2023 |
| 50090-6505-1 | 50090-6505 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6505-1) | May 30, 2023 |
| 50090-6505-2 | 50090-6505 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-6505-2) | May 30, 2023 |
| 50090-6506-0 | 50090-6506 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6506-0) | May 30, 2023 |
| 50090-6970-0 | 50090-6970 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6970-0) | December 21, 2023 |
| 50090-7358-0 | 50090-7358 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-7358-0) | October 17, 2024 |
| 50090-7358-1 | 50090-7358 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7358-1) | October 17, 2024 |
| 50090-7358-2 | 50090-7358 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-7358-2) | October 17, 2024 |
| 50090-7359-0 | 50090-7359 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7359-0) | October 17, 2024 |
| 50090-7384-0 | 50090-7384 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-7384-0) | October 21, 2024 |
| 50090-7384-1 | 50090-7384 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7384-1) | October 21, 2024 |
| 50090-7384-2 | 50090-7384 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-7384-2) | October 21, 2024 |
| 50090-7385-0 | 50090-7385 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7385-0) | October 21, 2024 |
| 50090-7386-0 | 50090-7386 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-7386-0) | October 21, 2024 |
| 50090-7386-1 | 50090-7386 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7386-1) | October 21, 2024 |
| 50090-7386-2 | 50090-7386 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-7386-2) | October 21, 2024 |
| 50090-7387-0 | 50090-7387 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7387-0) | October 21, 2024 |
| 50090-7528-0 | 50090-7528 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-7528-0) | April 7, 2025 |
| 50090-7528-1 | 50090-7528 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7528-1) | April 7, 2025 |
| 50090-7528-2 | 50090-7528 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-7528-2) | April 7, 2025 |
| 50090-7529-0 | 50090-7529 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7529-0) | April 7, 2025 |
| 50090-7532-0 | 50090-7532 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-7532-0) | April 8, 2025 |
| 50090-7532-1 | 50090-7532 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7532-1) | April 8, 2025 |
| 50090-7532-2 | 50090-7532 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-7532-2) | April 8, 2025 |
| 50090-7533-0 | 50090-7533 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7533-0) | April 8, 2025 |
| 50090-7574-0 | 50090-7574 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-7574-0) | June 9, 2025 |
| 50090-7574-1 | 50090-7574 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7574-1) | June 9, 2025 |
| 50090-7574-2 | 50090-7574 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-7574-2) | June 9, 2025 |
| 50090-7575-0 | 50090-7575 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7575-0) | June 9, 2025 |
| 50090-7806-0 | 50090-7806 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-7806-0) | December 2, 2025 |
| 50090-7806-1 | 50090-7806 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7806-1) | December 2, 2025 |
| 50090-7806-2 | 50090-7806 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-7806-2) | December 2, 2025 |
| 50090-7807-0 | 50090-7807 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7807-0) | December 2, 2025 |
| 16729-044-15 | 16729-044 | Accord Healthcare Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (16729-044-15) | July 13, 2021 |
| 16729-044-17 | 16729-044 | Accord Healthcare Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (16729-044-17) | August 2, 2018 |
| 16729-045-15 | 16729-045 | Accord Healthcare Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (16729-045-15) | July 13, 2021 |
| 16729-045-17 | 16729-045 | Accord Healthcare Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (16729-045-17) | August 6, 2018 |
| 16729-046-15 | 16729-046 | Accord Healthcare Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (16729-046-15) | July 13, 2021 |
| 16729-046-17 | 16729-046 | Accord Healthcare Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (16729-046-17) | August 6, 2018 |
| 16729-047-15 | 16729-047 | Accord Healthcare Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (16729-047-15) | July 13, 2021 |
| 16729-047-16 | 16729-047 | Accord Healthcare Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (16729-047-16) | August 6, 2018 |
| 68084-097-01 | 68084-097 | American Health Packaging | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-097-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-097-11) | August 14, 2013 |
| 68084-098-01 | 68084-098 | American Health Packaging | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-098-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-098-11) | July 9, 2013 |
| 68084-099-01 | 68084-099 | American Health Packaging | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-099-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-099-11) | September 19, 2013 |
| 68084-590-25 | 68084-590 | American Health Packaging | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-590-25) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-590-95) | March 18, 2013 |
| 71610-022-45 | 71610-022 | Aphena Pharma Solutions - Tennessee, LLC | 45 TABLET, FILM COATED in 1 BOTTLE (71610-022-45) | December 20, 2017 |
| 71610-036-15 | 71610-036 | Aphena Pharma Solutions - Tennessee, LLC | 15 TABLET, FILM COATED in 1 BOTTLE (71610-036-15) | January 26, 2018 |
| 71610-036-30 | 71610-036 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (71610-036-30) | January 26, 2018 |
| 71610-036-45 | 71610-036 | Aphena Pharma Solutions - Tennessee, LLC | 45 TABLET, FILM COATED in 1 BOTTLE (71610-036-45) | January 26, 2018 |
| 71610-036-60 | 71610-036 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (71610-036-60) | January 31, 2018 |
| 71610-163-15 | 71610-163 | Aphena Pharma Solutions - Tennessee, LLC | 15 TABLET, FILM COATED in 1 BOTTLE (71610-163-15) | October 1, 2018 |
| 71610-163-30 | 71610-163 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (71610-163-30) | October 1, 2018 |
| 71610-163-45 | 71610-163 | Aphena Pharma Solutions - Tennessee, LLC | 45 TABLET, FILM COATED in 1 BOTTLE (71610-163-45) | October 1, 2018 |
| 71610-633-15 | 71610-633 | Aphena Pharma Solutions - Tennessee, LLC | 15 TABLET, FILM COATED in 1 BOTTLE (71610-633-15) | February 7, 2022 |
| 71610-633-30 | 71610-633 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (71610-633-30) | February 7, 2022 |
| 71610-633-45 | 71610-633 | Aphena Pharma Solutions - Tennessee, LLC | 45 TABLET, FILM COATED in 1 BOTTLE (71610-633-45) | February 7, 2022 |
| 71610-633-60 | 71610-633 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (71610-633-60) | February 7, 2022 |
| 71610-744-15 | 71610-744 | Aphena Pharma Solutions - Tennessee, LLC | 15 TABLET, FILM COATED in 1 BOTTLE (71610-744-15) | October 24, 2023 |
| 71610-744-30 | 71610-744 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (71610-744-30) | October 24, 2023 |
| 71610-744-45 | 71610-744 | Aphena Pharma Solutions - Tennessee, LLC | 45 TABLET, FILM COATED in 1 BOTTLE (71610-744-45) | October 24, 2023 |
| 71610-744-53 | 71610-744 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE (71610-744-53) | October 24, 2023 |
| 71610-744-60 | 71610-744 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (71610-744-60) | October 24, 2023 |
| 71610-744-70 | 71610-744 | Aphena Pharma Solutions - Tennessee, LLC | 120 TABLET, FILM COATED in 1 BOTTLE (71610-744-70) | October 24, 2023 |
| 71610-745-15 | 71610-745 | Aphena Pharma Solutions - Tennessee, LLC | 15 TABLET, FILM COATED in 1 BOTTLE (71610-745-15) | October 24, 2023 |
| 71610-745-30 | 71610-745 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (71610-745-30) | October 24, 2023 |
| 71610-745-45 | 71610-745 | Aphena Pharma Solutions - Tennessee, LLC | 45 TABLET, FILM COATED in 1 BOTTLE (71610-745-45) | October 24, 2023 |
| 71610-745-53 | 71610-745 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE (71610-745-53) | October 24, 2023 |
| 71610-745-60 | 71610-745 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (71610-745-60) | October 24, 2023 |
| 71610-746-15 | 71610-746 | Aphena Pharma Solutions - Tennessee, LLC | 15 TABLET, FILM COATED in 1 BOTTLE (71610-746-15) | October 24, 2023 |
| 71610-746-30 | 71610-746 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (71610-746-30) | October 24, 2023 |
| 71610-746-45 | 71610-746 | Aphena Pharma Solutions - Tennessee, LLC | 45 TABLET, FILM COATED in 1 BOTTLE (71610-746-45) | October 24, 2023 |
| 71610-746-53 | 71610-746 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE (71610-746-53) | October 24, 2023 |
| 71610-746-60 | 71610-746 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (71610-746-60) | October 24, 2023 |
| 60505-2578-0 | 60505-2578 | Apotex Corp. | 10 BLISTER PACK in 1 CARTON (60505-2578-0) / 10 TABLET, FILM COATED in 1 BLISTER PACK | May 29, 2012 |
| 60505-2578-3 | 60505-2578 | Apotex Corp. | 30 TABLET, FILM COATED in 1 BOTTLE (60505-2578-3) | May 29, 2012 |
| 60505-2578-5 | 60505-2578 | Apotex Corp. | 500 TABLET, FILM COATED in 1 BOTTLE (60505-2578-5) | May 29, 2012 |
| 60505-2578-7 | 60505-2578 | Apotex Corp. | 5000 TABLET, FILM COATED in 1 BOTTLE (60505-2578-7) | May 29, 2012 |
| 60505-2578-8 | 60505-2578 | Apotex Corp. | 1000 TABLET, FILM COATED in 1 BOTTLE (60505-2578-8) | May 29, 2012 |
| 60505-2578-9 | 60505-2578 | Apotex Corp. | 90 TABLET, FILM COATED in 1 BOTTLE (60505-2578-9) | May 29, 2012 |
| 60505-2579-0 | 60505-2579 | Apotex Corp. | 10 BLISTER PACK in 1 CARTON (60505-2579-0) / 10 TABLET, FILM COATED in 1 BLISTER PACK | May 29, 2012 |
| 60505-2579-3 | 60505-2579 | Apotex Corp. | 30 TABLET, FILM COATED in 1 BOTTLE (60505-2579-3) | May 29, 2012 |
| 60505-2579-5 | 60505-2579 | Apotex Corp. | 500 TABLET, FILM COATED in 1 BOTTLE (60505-2579-5) | May 29, 2012 |
| 60505-2579-7 | 60505-2579 | Apotex Corp. | 5000 TABLET, FILM COATED in 1 BOTTLE (60505-2579-7) | May 29, 2012 |
| 60505-2579-8 | 60505-2579 | Apotex Corp. | 1000 TABLET, FILM COATED in 1 BOTTLE (60505-2579-8) | May 29, 2012 |
| 60505-2579-9 | 60505-2579 | Apotex Corp. | 90 TABLET, FILM COATED in 1 BOTTLE (60505-2579-9) | May 29, 2012 |
| 60505-2580-0 | 60505-2580 | Apotex Corp. | 10 BLISTER PACK in 1 CARTON (60505-2580-0) / 10 TABLET, FILM COATED in 1 BLISTER PACK | May 29, 2012 |
| 60505-2580-3 | 60505-2580 | Apotex Corp. | 30 TABLET, FILM COATED in 1 BOTTLE (60505-2580-3) | May 29, 2012 |
| 60505-2580-5 | 60505-2580 | Apotex Corp. | 500 TABLET, FILM COATED in 1 BOTTLE (60505-2580-5) | May 29, 2012 |
| 60505-2580-7 | 60505-2580 | Apotex Corp. | 4000 TABLET, FILM COATED in 1 BOTTLE (60505-2580-7) | May 29, 2012 |
| 60505-2580-8 | 60505-2580 | Apotex Corp. | 1000 TABLET, FILM COATED in 1 BOTTLE (60505-2580-8) | May 29, 2012 |
| 60505-2580-9 | 60505-2580 | Apotex Corp. | 90 TABLET, FILM COATED in 1 BOTTLE (60505-2580-9) | May 29, 2012 |
| 60505-2671-0 | 60505-2671 | Apotex Corp. | 10 BLISTER PACK in 1 CARTON (60505-2671-0) / 10 TABLET, FILM COATED in 1 BLISTER PACK | May 29, 2012 |
| 60505-2671-3 | 60505-2671 | Apotex Corp. | 30 TABLET, FILM COATED in 1 BOTTLE (60505-2671-3) | May 29, 2012 |
| 60505-2671-5 | 60505-2671 | Apotex Corp. | 500 TABLET, FILM COATED in 1 BOTTLE (60505-2671-5) | May 29, 2012 |
| 60505-2671-7 | 60505-2671 | Apotex Corp. | 2500 TABLET, FILM COATED in 1 BOTTLE (60505-2671-7) | May 29, 2012 |
| 60505-2671-8 | 60505-2671 | Apotex Corp. | 1000 TABLET, FILM COATED in 1 BOTTLE (60505-2671-8) | May 29, 2012 |
| 60505-2671-9 | 60505-2671 | Apotex Corp. | 90 TABLET, FILM COATED in 1 BOTTLE (60505-2671-9) | May 29, 2012 |
| 67877-511-05 | 67877-511 | Ascend Laboratories, LLC | 500 TABLET, FILM COATED in 1 BOTTLE (67877-511-05) | December 23, 2018 |
| 67877-511-10 | 67877-511 | Ascend Laboratories, LLC | 1000 TABLET, FILM COATED in 1 BOTTLE (67877-511-10) | December 23, 2018 |
| 67877-511-38 | 67877-511 | Ascend Laboratories, LLC | 10 BLISTER PACK in 1 CARTON (67877-511-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-511-33) | December 23, 2018 |
| 67877-511-55 | 67877-511 | Ascend Laboratories, LLC | 5000 TABLET, FILM COATED in 1 BOTTLE (67877-511-55) | December 23, 2018 |
| 67877-511-90 | 67877-511 | Ascend Laboratories, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (67877-511-90) | December 23, 2018 |
| 67877-512-05 | 67877-512 | Ascend Laboratories, LLC | 500 TABLET, FILM COATED in 1 BOTTLE (67877-512-05) | December 23, 2018 |
| 67877-512-10 | 67877-512 | Ascend Laboratories, LLC | 1000 TABLET, FILM COATED in 1 BOTTLE (67877-512-10) | December 23, 2018 |
| 67877-512-38 | 67877-512 | Ascend Laboratories, LLC | 10 BLISTER PACK in 1 CARTON (67877-512-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-512-33) | December 23, 2018 |
| 67877-512-44 | 67877-512 | Ascend Laboratories, LLC | 4000 TABLET, FILM COATED in 1 BOTTLE (67877-512-44) | December 23, 2018 |
| 67877-512-90 | 67877-512 | Ascend Laboratories, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (67877-512-90) | December 23, 2018 |
| 67877-513-05 | 67877-513 | Ascend Laboratories, LLC | 500 TABLET, FILM COATED in 1 BOTTLE (67877-513-05) | December 23, 2018 |
| 67877-513-10 | 67877-513 | Ascend Laboratories, LLC | 1000 TABLET, FILM COATED in 1 BOTTLE (67877-513-10) | December 23, 2018 |
| 67877-513-23 | 67877-513 | Ascend Laboratories, LLC | 2000 TABLET, FILM COATED in 1 BOTTLE (67877-513-23) | December 23, 2018 |
| 67877-513-38 | 67877-513 | Ascend Laboratories, LLC | 10 BLISTER PACK in 1 CARTON (67877-513-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-513-33) | December 23, 2018 |
| 67877-513-90 | 67877-513 | Ascend Laboratories, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (67877-513-90) | December 23, 2018 |
| 67877-514-05 | 67877-514 | Ascend Laboratories, LLC | 500 TABLET, FILM COATED in 1 BOTTLE (67877-514-05) | December 23, 2018 |
| 67877-514-10 | 67877-514 | Ascend Laboratories, LLC | 1000 TABLET, FILM COATED in 1 BOTTLE (67877-514-10) | December 23, 2018 |
| 67877-514-38 | 67877-514 | Ascend Laboratories, LLC | 10 BLISTER PACK in 1 CARTON (67877-514-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-514-33) | December 23, 2018 |
| 67877-514-90 | 67877-514 | Ascend Laboratories, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (67877-514-90) | December 23, 2018 |
| 76420-943-00 | 76420-943 | Asclemed USA, Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (76420-943-00) | April 8, 2025 |
| 76420-943-05 | 76420-943 | Asclemed USA, Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (76420-943-05) | April 8, 2025 |
| 76420-943-12 | 76420-943 | Asclemed USA, Inc. | 120 TABLET, FILM COATED in 1 BOTTLE (76420-943-12) | April 8, 2025 |
| 76420-943-20 | 76420-943 | Asclemed USA, Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (76420-943-20) | April 8, 2025 |
| 76420-943-30 | 76420-943 | Asclemed USA, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (76420-943-30) | April 8, 2025 |
| 76420-943-38 | 76420-943 | Asclemed USA, Inc. | 10 BLISTER PACK in 1 CARTON (76420-943-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK | April 8, 2025 |
| 76420-943-55 | 76420-943 | Asclemed USA, Inc. | 5000 TABLET, FILM COATED in 1 BOTTLE (76420-943-55) | April 8, 2025 |
| 76420-943-60 | 76420-943 | Asclemed USA, Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (76420-943-60) | April 8, 2025 |
| 76420-943-90 | 76420-943 | Asclemed USA, Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (76420-943-90) | April 8, 2025 |
| 76420-945-00 | 76420-945 | Asclemed USA, Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (76420-945-00) | April 8, 2025 |
| 76420-945-05 | 76420-945 | Asclemed USA, Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (76420-945-05) | April 8, 2025 |
| 76420-945-12 | 76420-945 | Asclemed USA, Inc. | 120 TABLET, FILM COATED in 1 BOTTLE (76420-945-12) | April 8, 2025 |
| 76420-945-20 | 76420-945 | Asclemed USA, Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (76420-945-20) | April 8, 2025 |
| 76420-945-30 | 76420-945 | Asclemed USA, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (76420-945-30) | April 8, 2025 |
| 76420-945-38 | 76420-945 | Asclemed USA, Inc. | 10 BLISTER PACK in 1 CARTON (76420-945-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK | April 8, 2025 |
| 76420-945-44 | 76420-945 | Asclemed USA, Inc. | 4000 TABLET, FILM COATED in 1 BOTTLE (76420-945-44) | April 8, 2025 |
| 76420-945-60 | 76420-945 | Asclemed USA, Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (76420-945-60) | April 8, 2025 |
| 76420-945-90 | 76420-945 | Asclemed USA, Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (76420-945-90) | April 8, 2025 |
| 76420-946-00 | 76420-946 | Asclemed USA, Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (76420-946-00) | April 8, 2025 |
| 76420-946-05 | 76420-946 | Asclemed USA, Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (76420-946-05) | April 8, 2025 |
| 76420-946-12 | 76420-946 | Asclemed USA, Inc. | 120 TABLET, FILM COATED in 1 BOTTLE (76420-946-12) | April 8, 2025 |
| 76420-946-20 | 76420-946 | Asclemed USA, Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (76420-946-20) | April 8, 2025 |
| 76420-946-23 | 76420-946 | Asclemed USA, Inc. | 2000 TABLET, FILM COATED in 1 BOTTLE (76420-946-23) | April 8, 2025 |
| 76420-946-30 | 76420-946 | Asclemed USA, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (76420-946-30) | April 8, 2025 |
| 76420-946-38 | 76420-946 | Asclemed USA, Inc. | 10 BLISTER PACK in 1 CARTON (76420-946-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK | April 8, 2025 |
| 76420-946-60 | 76420-946 | Asclemed USA, Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (76420-946-60) | April 8, 2025 |
| 76420-946-90 | 76420-946 | Asclemed USA, Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (76420-946-90) | April 8, 2025 |
| 76420-948-00 | 76420-948 | Asclemed USA, Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (76420-948-00) | April 8, 2025 |
| 76420-948-05 | 76420-948 | Asclemed USA, Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (76420-948-05) | April 8, 2025 |
| 76420-948-12 | 76420-948 | Asclemed USA, Inc. | 120 TABLET, FILM COATED in 1 BOTTLE (76420-948-12) | April 8, 2025 |
| 76420-948-20 | 76420-948 | Asclemed USA, Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (76420-948-20) | April 8, 2025 |
| 76420-948-30 | 76420-948 | Asclemed USA, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (76420-948-30) | April 8, 2025 |
| 76420-948-38 | 76420-948 | Asclemed USA, Inc. | 10 BLISTER PACK in 1 CARTON (76420-948-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK | April 8, 2025 |
| 76420-948-60 | 76420-948 | Asclemed USA, Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (76420-948-60) | April 8, 2025 |
| 76420-948-90 | 76420-948 | Asclemed USA, Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (76420-948-90) | April 8, 2025 |
| 59651-606-05 | 59651-606 | Aurobindo Pharma Limited | 500 TABLET, FILM COATED in 1 BOTTLE (59651-606-05) | February 13, 2024 |
| 59651-606-12 | 59651-606 | Aurobindo Pharma Limited | 120000 TABLET, FILM COATED in 1 BAG (59651-606-12) | February 13, 2024 |
| 59651-606-30 | 59651-606 | Aurobindo Pharma Limited | 30 TABLET, FILM COATED in 1 BOTTLE (59651-606-30) | February 13, 2024 |
| 59651-606-90 | 59651-606 | Aurobindo Pharma Limited | 90 TABLET, FILM COATED in 1 BOTTLE (59651-606-90) | February 13, 2024 |
| 59651-606-99 | 59651-606 | Aurobindo Pharma Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (59651-606-99) | February 13, 2024 |
| 59651-607-05 | 59651-607 | Aurobindo Pharma Limited | 500 TABLET, FILM COATED in 1 BOTTLE (59651-607-05) | February 13, 2024 |
| 59651-607-30 | 59651-607 | Aurobindo Pharma Limited | 30 TABLET, FILM COATED in 1 BOTTLE (59651-607-30) | February 13, 2024 |
| 59651-607-60 | 59651-607 | Aurobindo Pharma Limited | 60000 TABLET, FILM COATED in 1 BAG (59651-607-60) | February 13, 2024 |
| 59651-607-90 | 59651-607 | Aurobindo Pharma Limited | 90 TABLET, FILM COATED in 1 BOTTLE (59651-607-90) | February 13, 2024 |
| 59651-607-99 | 59651-607 | Aurobindo Pharma Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (59651-607-99) | February 13, 2024 |
| 59651-608-05 | 59651-608 | Aurobindo Pharma Limited | 500 TABLET, FILM COATED in 1 BOTTLE (59651-608-05) | February 13, 2024 |
| 59651-608-30 | 59651-608 | Aurobindo Pharma Limited | 30 TABLET, FILM COATED in 1 BOTTLE (59651-608-30) | February 13, 2024 |
| 59651-608-62 | 59651-608 | Aurobindo Pharma Limited | 30000 TABLET, FILM COATED in 1 BAG (59651-608-62) | February 13, 2024 |
| 59651-608-90 | 59651-608 | Aurobindo Pharma Limited | 90 TABLET, FILM COATED in 1 BOTTLE (59651-608-90) | February 13, 2024 |
| 59651-608-99 | 59651-608 | Aurobindo Pharma Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (59651-608-99) | February 13, 2024 |
| 59651-609-05 | 59651-609 | Aurobindo Pharma Limited | 500 TABLET, FILM COATED in 1 BOTTLE (59651-609-05) | February 13, 2024 |
| 59651-609-30 | 59651-609 | Aurobindo Pharma Limited | 30 TABLET, FILM COATED in 1 BOTTLE (59651-609-30) | February 13, 2024 |
| 59651-609-55 | 59651-609 | Aurobindo Pharma Limited | 15000 TABLET, FILM COATED in 1 BAG (59651-609-55) | February 13, 2024 |
| 59651-609-90 | 59651-609 | Aurobindo Pharma Limited | 90 TABLET, FILM COATED in 1 BOTTLE (59651-609-90) | February 13, 2024 |
| 59651-609-99 | 59651-609 | Aurobindo Pharma Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (59651-609-99) | February 13, 2024 |
| 50268-093-15 | 50268-093 | AvPAK | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-093-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-093-11) | June 28, 2016 |
| 50268-094-15 | 50268-094 | AvPAK | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-094-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-094-11) | June 28, 2016 |
| 50268-095-15 | 50268-095 | AvPAK | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-095-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-095-11) | June 28, 2016 |
| 50268-096-12 | 50268-096 | AvPAK | 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-096-12) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-096-11) | June 28, 2016 |
| 70377-077-11 | 70377-077 | Biocon Pharma Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (70377-077-11) | March 1, 2023 |
| 70377-077-12 | 70377-077 | Biocon Pharma Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (70377-077-12) | March 1, 2023 |
| 70377-077-13 | 70377-077 | Biocon Pharma Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (70377-077-13) | March 1, 2023 |
| 70377-078-11 | 70377-078 | Biocon Pharma Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (70377-078-11) | March 1, 2023 |
| 70377-078-12 | 70377-078 | Biocon Pharma Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (70377-078-12) | March 1, 2023 |
| 70377-078-13 | 70377-078 | Biocon Pharma Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (70377-078-13) | March 1, 2023 |
| 70377-079-11 | 70377-079 | Biocon Pharma Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (70377-079-11) | March 1, 2023 |
| 70377-079-12 | 70377-079 | Biocon Pharma Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (70377-079-12) | March 1, 2023 |
| 70377-079-13 | 70377-079 | Biocon Pharma Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (70377-079-13) | March 1, 2023 |
| 70377-080-11 | 70377-080 | Biocon Pharma Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (70377-080-11) | March 1, 2023 |
| 70377-080-12 | 70377-080 | Biocon Pharma Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (70377-080-12) | March 1, 2023 |
| 70377-080-13 | 70377-080 | Biocon Pharma Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (70377-080-13) | March 1, 2023 |
| 63629-8469-1 | 63629-8469 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (63629-8469-1) | May 19, 2016 |
| 63629-8470-1 | 63629-8470 | Bryant Ranch Prepack | 500 TABLET, FILM COATED in 1 BOTTLE (63629-8470-1) | May 19, 2016 |
| 63629-8471-1 | 63629-8471 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (63629-8471-1) | May 19, 2016 |
| 63629-8472-1 | 63629-8472 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (63629-8472-1) | May 19, 2016 |
| 71335-1010-1 | 71335-1010 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1010-1) | November 29, 2018 |
| 71335-1010-2 | 71335-1010 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1010-2) | June 17, 2021 |
| 71335-1010-3 | 71335-1010 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1010-3) | November 19, 2018 |
| 71335-1010-4 | 71335-1010 | Bryant Ranch Prepack | 9 TABLET, FILM COATED in 1 BOTTLE (71335-1010-4) | May 30, 2024 |
| 71335-1010-5 | 71335-1010 | Bryant Ranch Prepack | 28 TABLET, FILM COATED in 1 BOTTLE (71335-1010-5) | May 30, 2024 |
| 71335-1010-6 | 71335-1010 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1010-6) | May 30, 2024 |
| 71335-1010-7 | 71335-1010 | Bryant Ranch Prepack | 180 TABLET, FILM COATED in 1 BOTTLE (71335-1010-7) | May 30, 2024 |
| 71335-1010-8 | 71335-1010 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1010-8) | May 30, 2024 |
| 71335-1010-9 | 71335-1010 | Bryant Ranch Prepack | 7 TABLET, FILM COATED in 1 BOTTLE (71335-1010-9) | May 30, 2024 |
| 71335-1011-1 | 71335-1011 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1011-1) | November 27, 2018 |
| 71335-1011-2 | 71335-1011 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1011-2) | May 30, 2024 |
| 71335-1011-3 | 71335-1011 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1011-3) | December 11, 2018 |
| 71335-1011-4 | 71335-1011 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1011-4) | May 30, 2024 |
| 71335-1011-5 | 71335-1011 | Bryant Ranch Prepack | 180 TABLET, FILM COATED in 1 BOTTLE (71335-1011-5) | May 30, 2024 |
| 71335-1011-6 | 71335-1011 | Bryant Ranch Prepack | 10 TABLET, FILM COATED in 1 BOTTLE (71335-1011-6) | May 30, 2024 |
| 71335-1011-7 | 71335-1011 | Bryant Ranch Prepack | 7 TABLET, FILM COATED in 1 BOTTLE (71335-1011-7) | May 30, 2024 |
| 71335-1011-8 | 71335-1011 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1011-8) | May 30, 2024 |
| 71335-1051-1 | 71335-1051 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1051-1) | January 4, 2019 |
| 71335-1051-2 | 71335-1051 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1051-2) | December 9, 2024 |
| 71335-1051-3 | 71335-1051 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1051-3) | February 6, 2019 |
| 71335-1051-4 | 71335-1051 | Bryant Ranch Prepack | 9 TABLET, FILM COATED in 1 BOTTLE (71335-1051-4) | December 9, 2024 |
| 71335-1051-5 | 71335-1051 | Bryant Ranch Prepack | 28 TABLET, FILM COATED in 1 BOTTLE (71335-1051-5) | December 9, 2024 |
| 71335-1051-6 | 71335-1051 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1051-6) | December 9, 2024 |
| 71335-1051-7 | 71335-1051 | Bryant Ranch Prepack | 180 TABLET, FILM COATED in 1 BOTTLE (71335-1051-7) | December 9, 2024 |
| 71335-1051-8 | 71335-1051 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1051-8) | December 9, 2024 |
| 71335-1051-9 | 71335-1051 | Bryant Ranch Prepack | 7 TABLET, FILM COATED in 1 BOTTLE (71335-1051-9) | December 9, 2024 |
| 71335-1126-1 | 71335-1126 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1126-1) | March 1, 2019 |
| 71335-1126-2 | 71335-1126 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1126-2) | October 31, 2024 |
| 71335-1126-3 | 71335-1126 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1126-3) | February 28, 2019 |
| 71335-1126-4 | 71335-1126 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1126-4) | October 31, 2024 |
| 71335-1126-5 | 71335-1126 | Bryant Ranch Prepack | 180 TABLET, FILM COATED in 1 BOTTLE (71335-1126-5) | October 31, 2024 |
| 71335-1126-6 | 71335-1126 | Bryant Ranch Prepack | 10 TABLET, FILM COATED in 1 BOTTLE (71335-1126-6) | October 31, 2024 |
| 71335-1126-7 | 71335-1126 | Bryant Ranch Prepack | 7 TABLET, FILM COATED in 1 BOTTLE (71335-1126-7) | October 31, 2024 |
| 71335-1336-1 | 71335-1336 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1336-1) | January 20, 2020 |
| 71335-1336-2 | 71335-1336 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1336-2) | July 9, 2024 |
| 71335-1336-3 | 71335-1336 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1336-3) | September 10, 2019 |
| 71335-1336-4 | 71335-1336 | Bryant Ranch Prepack | 180 TABLET, FILM COATED in 1 BOTTLE (71335-1336-4) | July 9, 2024 |
| 71335-1388-1 | 71335-1388 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1388-1) | November 4, 2019 |
| 71335-1388-2 | 71335-1388 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1388-2) | November 20, 2019 |
| 71335-1388-3 | 71335-1388 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1388-3) | October 31, 2024 |
| 71335-1388-4 | 71335-1388 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1388-4) | October 31, 2024 |
| 71335-1388-5 | 71335-1388 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1388-5) | October 6, 2020 |
| 71335-1388-6 | 71335-1388 | Bryant Ranch Prepack | 180 TABLET, FILM COATED in 1 BOTTLE (71335-1388-6) | October 31, 2024 |
| 71335-1507-1 | 71335-1507 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1507-1) | February 10, 2020 |
| 71335-1507-2 | 71335-1507 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1507-2) | March 16, 2020 |
| 71335-1507-3 | 71335-1507 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1507-3) | February 25, 2020 |
| 71335-1507-4 | 71335-1507 | Bryant Ranch Prepack | 9 TABLET, FILM COATED in 1 BOTTLE (71335-1507-4) | October 31, 2024 |
| 71335-1507-5 | 71335-1507 | Bryant Ranch Prepack | 28 TABLET, FILM COATED in 1 BOTTLE (71335-1507-5) | October 31, 2024 |
| 71335-1507-6 | 71335-1507 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1507-6) | October 31, 2024 |
| 71335-1507-7 | 71335-1507 | Bryant Ranch Prepack | 180 TABLET, FILM COATED in 1 BOTTLE (71335-1507-7) | October 31, 2024 |
| 71335-1507-8 | 71335-1507 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1507-8) | October 31, 2024 |
| 71335-1507-9 | 71335-1507 | Bryant Ranch Prepack | 7 TABLET, FILM COATED in 1 BOTTLE (71335-1507-9) | October 31, 2024 |
| 71335-1710-1 | 71335-1710 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1710-1) | February 3, 2021 |
| 71335-1710-2 | 71335-1710 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1710-2) | December 4, 2020 |
| 71335-1710-3 | 71335-1710 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1710-3) | May 30, 2024 |
| 71335-1710-4 | 71335-1710 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1710-4) | April 19, 2021 |
| 71335-1710-5 | 71335-1710 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1710-5) | November 19, 2021 |
| 71335-1710-6 | 71335-1710 | Bryant Ranch Prepack | 180 TABLET, FILM COATED in 1 BOTTLE (71335-1710-6) | May 30, 2024 |
| 71335-2241-1 | 71335-2241 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2241-1) | November 7, 2023 |
| 71335-2241-2 | 71335-2241 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2241-2) | October 10, 2023 |
| 71335-2241-3 | 71335-2241 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2241-3) | January 31, 2025 |
| 71335-2241-4 | 71335-2241 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-2241-4) | January 23, 2024 |
| 71335-2241-5 | 71335-2241 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2241-5) | January 31, 2025 |
| 71335-2241-6 | 71335-2241 | Bryant Ranch Prepack | 180 TABLET, FILM COATED in 1 BOTTLE (71335-2241-6) | January 31, 2025 |
| 71335-2407-1 | 71335-2407 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2407-1) | September 10, 2024 |
| 71335-2407-2 | 71335-2407 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2407-2) | November 1, 2024 |
| 71335-2407-3 | 71335-2407 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2407-3) | May 29, 2024 |
| 71335-2407-4 | 71335-2407 | Bryant Ranch Prepack | 180 TABLET, FILM COATED in 1 BOTTLE (71335-2407-4) | November 1, 2024 |
| 71335-2493-1 | 71335-2493 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2493-1) | September 10, 2024 |
| 71335-2493-2 | 71335-2493 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2493-2) | November 1, 2024 |
| 71335-2493-3 | 71335-2493 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2493-3) | September 9, 2024 |
| 71335-2493-4 | 71335-2493 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2493-4) | November 1, 2024 |
| 71335-2493-5 | 71335-2493 | Bryant Ranch Prepack | 180 TABLET, FILM COATED in 1 BOTTLE (71335-2493-5) | November 1, 2024 |
| 71335-2493-6 | 71335-2493 | Bryant Ranch Prepack | 10 TABLET, FILM COATED in 1 BOTTLE (71335-2493-6) | November 1, 2024 |
| 71335-2493-7 | 71335-2493 | Bryant Ranch Prepack | 7 TABLET, FILM COATED in 1 BOTTLE (71335-2493-7) | November 1, 2024 |
| 71335-2799-1 | 71335-2799 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2799-1) | October 13, 2025 |
| 71335-2799-2 | 71335-2799 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2799-2) | October 13, 2025 |
| 71335-2799-3 | 71335-2799 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2799-3) | October 13, 2025 |
| 71335-2799-4 | 71335-2799 | Bryant Ranch Prepack | 9 TABLET, FILM COATED in 1 BOTTLE (71335-2799-4) | October 13, 2025 |
| 71335-2799-5 | 71335-2799 | Bryant Ranch Prepack | 28 TABLET, FILM COATED in 1 BOTTLE (71335-2799-5) | October 13, 2025 |
| 71335-2799-6 | 71335-2799 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-2799-6) | October 13, 2025 |
| 71335-2799-7 | 71335-2799 | Bryant Ranch Prepack | 180 TABLET, FILM COATED in 1 BOTTLE (71335-2799-7) | October 13, 2025 |
| 71335-2799-8 | 71335-2799 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2799-8) | October 13, 2025 |
| 71335-2799-9 | 71335-2799 | Bryant Ranch Prepack | 7 TABLET, FILM COATED in 1 BOTTLE (71335-2799-9) | October 13, 2025 |
| 71335-2977-1 | 71335-2977 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2977-1) | November 6, 2025 |
| 71335-2977-2 | 71335-2977 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2977-2) | November 6, 2025 |
| 71335-2977-3 | 71335-2977 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2977-3) | November 6, 2025 |
| 71335-2977-4 | 71335-2977 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-2977-4) | November 6, 2025 |
| 71335-2977-5 | 71335-2977 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2977-5) | November 6, 2025 |
| 71335-2977-6 | 71335-2977 | Bryant Ranch Prepack | 180 TABLET, FILM COATED in 1 BOTTLE (71335-2977-6) | November 6, 2025 |
| 71335-3144-1 | 71335-3144 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-3144-1) | June 18, 2026 |
| 71335-3144-2 | 71335-3144 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-3144-2) | June 18, 2026 |
| 71335-3144-3 | 71335-3144 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-3144-3) | June 18, 2026 |
| 71335-3144-4 | 71335-3144 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-3144-4) | June 18, 2026 |
| 71335-3144-5 | 71335-3144 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-3144-5) | June 18, 2026 |
| 71335-3144-6 | 71335-3144 | Bryant Ranch Prepack | 180 TABLET, FILM COATED in 1 BOTTLE (71335-3144-6) | June 18, 2026 |
| 71335-3179-1 | 71335-3179 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-3179-1) | September 8, 2026 |
| 71335-3179-2 | 71335-3179 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-3179-2) | September 8, 2026 |
| 71335-3179-3 | 71335-3179 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-3179-3) | September 8, 2026 |
| 71335-3179-4 | 71335-3179 | Bryant Ranch Prepack | 180 TABLET, FILM COATED in 1 BOTTLE (71335-3179-4) | September 8, 2026 |
| 71335-9711-1 | 71335-9711 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-9711-1) | June 26, 2023 |
| 71335-9711-2 | 71335-9711 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-9711-2) | July 16, 2024 |
| 71335-9711-3 | 71335-9711 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-9711-3) | May 12, 2023 |
| 71335-9711-4 | 71335-9711 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-9711-4) | July 16, 2024 |
| 71335-9711-5 | 71335-9711 | Bryant Ranch Prepack | 180 TABLET, FILM COATED in 1 BOTTLE (71335-9711-5) | July 16, 2024 |
| 71335-9711-6 | 71335-9711 | Bryant Ranch Prepack | 10 TABLET, FILM COATED in 1 BOTTLE (71335-9711-6) | July 16, 2024 |
| 71335-9711-7 | 71335-9711 | Bryant Ranch Prepack | 7 TABLET, FILM COATED in 1 BOTTLE (71335-9711-7) | July 16, 2024 |
| 71335-9711-8 | 71335-9711 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-9711-8) | July 16, 2024 |
| 72162-1554-9 | 72162-1554 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (72162-1554-9) | May 19, 2016 |
| 72162-1555-5 | 72162-1555 | Bryant Ranch Prepack | 500 TABLET, FILM COATED in 1 BOTTLE (72162-1555-5) | May 19, 2016 |
| 72162-1555-9 | 72162-1555 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (72162-1555-9) | May 19, 2016 |
| 72162-1556-9 | 72162-1556 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (72162-1556-9) | May 19, 2016 |
| 72162-1712-2 | 72162-1712 | Bryant Ranch Prepack | 9 TABLET, FILM COATED in 1 BOTTLE (72162-1712-2) | July 17, 2024 |
| 72162-1712-3 | 72162-1712 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (72162-1712-3) | July 17, 2024 |
| 72162-1712-4 | 72162-1712 | Bryant Ranch Prepack | 28 TABLET, FILM COATED in 1 BOTTLE (72162-1712-4) | July 17, 2024 |
| 72162-1712-6 | 72162-1712 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (72162-1712-6) | July 17, 2024 |
| 72162-1712-7 | 72162-1712 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (72162-1712-7) | July 17, 2024 |
| 72162-1712-9 | 72162-1712 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (72162-1712-9) | July 17, 2024 |
| 72162-2238-9 | 72162-2238 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (72162-2238-9) | May 19, 2016 |
| 31722-424-05 | 31722-424 | Camber Pharmaceuticals, Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (31722-424-05) | September 12, 2023 |
| 31722-424-10 | 31722-424 | Camber Pharmaceuticals, Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (31722-424-10) | September 12, 2023 |
| 31722-424-90 | 31722-424 | Camber Pharmaceuticals, Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (31722-424-90) | September 12, 2023 |
| 31722-425-05 | 31722-425 | Camber Pharmaceuticals, Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (31722-425-05) | September 12, 2023 |
| 31722-425-10 | 31722-425 | Camber Pharmaceuticals, Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (31722-425-10) | September 12, 2023 |
| 31722-425-90 | 31722-425 | Camber Pharmaceuticals, Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (31722-425-90) | September 12, 2023 |
| 31722-426-05 | 31722-426 | Camber Pharmaceuticals, Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (31722-426-05) | September 12, 2023 |
| 31722-426-10 | 31722-426 | Camber Pharmaceuticals, Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (31722-426-10) | April 25, 2024 |
| 31722-426-90 | 31722-426 | Camber Pharmaceuticals, Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (31722-426-90) | September 12, 2023 |
| 31722-427-05 | 31722-427 | Camber Pharmaceuticals, Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (31722-427-05) | September 12, 2023 |
| 31722-427-10 | 31722-427 | Camber Pharmaceuticals, Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (31722-427-10) | April 25, 2024 |
| 31722-427-90 | 31722-427 | Camber Pharmaceuticals, Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (31722-427-90) | September 12, 2023 |
| 55154-0284-6 | 55154-0284 | Cardinal Health 107, LLC | 6 BLISTER PACK in 1 BAG (55154-0284-6) / 1 TABLET, FILM COATED in 1 BLISTER PACK | July 24, 2026 |
| 55154-4166-0 | 55154-4166 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-4166-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | October 31, 2014 |
| 55154-4384-6 | 55154-4384 | Cardinal Health 107, LLC | 6 BLISTER PACK in 1 BAG (55154-4384-6) / 1 TABLET, FILM COATED in 1 BLISTER PACK | January 23, 2014 |
| 55154-5884-0 | 55154-5884 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-5884-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | May 29, 2012 |
| 55154-6634-0 | 55154-6634 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-6634-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | July 9, 2013 |
| 55154-6635-0 | 55154-6635 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-6635-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | July 29, 2013 |
| 55154-6646-0 | 55154-6646 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-6646-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | July 9, 2013 |
| 55154-7289-0 | 55154-7289 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-7289-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | October 31, 2014 |
| 55154-7628-0 | 55154-7628 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-7628-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | October 31, 2014 |
| 55154-7630-0 | 55154-7630 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-7630-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | May 29, 2012 |
| 69097-897-05 | 69097-897 | Cipla USA Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (69097-897-05) | August 4, 2016 |
| 69097-897-15 | 69097-897 | Cipla USA Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (69097-897-15) | August 4, 2016 |
| 69097-898-05 | 69097-898 | Cipla USA Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (69097-898-05) | August 4, 2016 |
| 69097-898-12 | 69097-898 | Cipla USA Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (69097-898-12) | August 4, 2016 |
| 69097-899-05 | 69097-899 | Cipla USA Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (69097-899-05) | August 4, 2016 |
| 69097-899-15 | 69097-899 | Cipla USA Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (69097-899-15) | August 4, 2016 |
| 69097-911-05 | 69097-911 | Cipla USA Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (69097-911-05) | August 4, 2016 |
| 69097-911-12 | 69097-911 | Cipla USA Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (69097-911-12) | August 4, 2016 |
| 69097-944-05 | 69097-944 | Cipla USA Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (69097-944-05) | November 16, 2017 |
| 69097-944-15 | 69097-944 | Cipla USA Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (69097-944-15) | November 16, 2017 |
| 69097-945-05 | 69097-945 | Cipla USA Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (69097-945-05) | November 16, 2017 |
| 69097-945-12 | 69097-945 | Cipla USA Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (69097-945-12) | November 16, 2017 |
| 69097-946-05 | 69097-946 | Cipla USA Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (69097-946-05) | November 16, 2017 |
| 69097-946-15 | 69097-946 | Cipla USA Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (69097-946-15) | November 16, 2017 |
| 69097-947-05 | 69097-947 | Cipla USA Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (69097-947-05) | November 16, 2017 |
| 69097-947-12 | 69097-947 | Cipla USA Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (69097-947-12) | November 16, 2017 |
| 67046-1442-3 | 67046-1442 | Coupler LLC | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1442-3) | February 11, 2025 |
| 67046-1453-3 | 67046-1453 | Coupler LLC | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1453-3) | February 7, 2025 |
| 67046-1491-3 | 67046-1491 | Coupler LLC | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1491-3) | January 29, 2025 |
| 67046-1505-3 | 67046-1505 | Coupler LLC | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1505-3) | January 25, 2025 |
| 67046-1526-3 | 67046-1526 | Coupler LLC | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1526-3) | February 27, 2025 |
| 67046-1529-3 | 67046-1529 | Coupler LLC | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1529-3) | March 10, 2025 |
| 67046-1593-3 | 67046-1593 | Coupler LLC | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1593-3) | September 16, 2025 |
| 67046-1643-3 | 67046-1643 | Coupler LLC | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1643-3) | January 7, 2026 |
| 67046-1666-3 | 67046-1666 | Coupler LLC | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1666-3) | April 16, 2026 |
| 67046-1677-3 | 67046-1677 | Coupler LLC | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1677-3) | May 21, 2026 |
| 72189-226-30 | 72189-226 | DIRECT RX | 30 TABLET, FILM COATED in 1 BOTTLE (72189-226-30) | June 1, 2021 |
| 72189-226-90 | 72189-226 | DIRECT RX | 90 TABLET, FILM COATED in 1 BOTTLE (72189-226-90) | June 1, 2021 |
| 72189-537-30 | 72189-537 | Direct_Rx | 30 TABLET, FILM COATED in 1 BOTTLE (72189-537-30) | February 26, 2024 |
| 72189-537-90 | 72189-537 | Direct_Rx | 90 TABLET, FILM COATED in 1 BOTTLE (72189-537-90) | February 26, 2024 |
| 72189-587-30 | 72189-587 | Direct_Rx | 30 TABLET, FILM COATED in 1 BOTTLE (72189-587-30) | October 4, 2024 |
| 72189-587-90 | 72189-587 | Direct_Rx | 90 TABLET, FILM COATED in 1 BOTTLE (72189-587-90) | October 4, 2024 |
| 72189-681-30 | 72189-681 | Direct_Rx | 30 TABLET, FILM COATED in 1 BOTTLE (72189-681-30) | July 15, 2026 |
| 72189-557-30 | 72189-557 | Direct_rx | 30 TABLET, FILM COATED in 1 BOTTLE (72189-557-30) | June 14, 2024 |
| 72189-557-90 | 72189-557 | Direct_rx | 90 TABLET, FILM COATED in 1 BOTTLE (72189-557-90) | June 14, 2024 |
| 42385-940-01 | 42385-940 | Laurus Labs Limited | 100 TABLET, FILM COATED in 1 BOTTLE (42385-940-01) | January 23, 2024 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
| Enforcement | FDA | Recall records |
Generated September 25, 2026 · 13 sections on this page.